Recall Z-1622-2020— Respironics California, LLC

Name: FDA recall Z-1622-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-05

Class II · Ongoing

Class II FDA medical device recall by Respironics California, LLC, initiated 2020-03-05. It names one FDA 510(k) clearance: K082660. Product: Philips V60 Ventilators with Power Management PCBA part number 1055906. Reason: Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia.

Recalling firm: Respironics California, LLC
Classification: Class II
Status: Ongoing
Initiated: 2020-03-05
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K082660 — V60 VENTILATOR, MODEL V8000Respironics California, Inc.·cleared 2009-01-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips V60 Ventilators with Power Management PCBA part number 1055906

Reason for recall

Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia

Data sourced from openFDA. This site is unofficial and independent of the FDA.